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news.Girindus, a company into the manufacturing of oligonucleotides for therapeutics, has bagged a contract to work on validation of a manufacturing process for an oligonucleotide product currently in Phase III clinical trials.
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Girindus said that the oligonucleotide product is a single strand phosphorothioate compound which has been granted an orphan drug designation.
Girindus stated that the process validation program to be initiated by Girindus in 2010 is followed by a program for a small molecule product being developed for an in-vivo imaging application in January.
Both validation projects are being carried out at the FDA inspected facility of Girindus America in Cincinnati, Ohio.
Girindus has appointed Mark Guzman as validation consultant to support the validation efforts of the team.
Prior to joining Girindus Dr Guzman has worked with Pfizer and Dynavax, where he took up the responsibility in the validation of manufacturing processes for complex oligonucleotide products.
Martin Weiland, speaker of the management board of Girindus, said: “The awarding of these two contracts are significant steps in our commercial development strategy.”